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In order to standardize the review and comment of national key monitoring drug prescriptions （medical orders） by medical institutions at all levels， the Sichuan Academy of Medical Sciences·Sichuan Provincial People’s Hospital took the lead in compiling the Review and Comment Rules of National Key Monitoring Drugs prescriptions （Medical Orders） herein after referred to as the Rules in accordance with the Second Batch of National Key Monitoring Rational Drug Use List （hereinafter referred to as the List） issued by the National Health Commission confirmed in Jan. 13， 2023. According to the laws and drug instructions issued by the national drug regulatory department， clinical guidelines and expert consensus， combined with the actual situation of patients （including age， body weight， liver and kidney function）， the writing group classified the common and unreasonable drug use problems for 30 kinds of drugs included in the List and develop the review and comment details. After two rounds of Delphi method questionnaire research and experts’ online meetings， and reviewed by the steering committee， the final Rules was formed. The Rules aim to provide reference for the evaluation of the rational use of drugs included in the List by medical institutions， so as to realize the standardized management of key monitoring drugs， promote the rational drug use in medical institutions， and ensure the safety of drug use for patients.
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In order to strengthen the supervision of the use of drugs in hospitals，the Sichuan Academy of Medical Sciences· Sichuan Provincial People’s Hospital took the lead in compiling the Principles for the Rational Use of National Key Monitoring Drugs （the Second Batch） with a number of experts from multiple medical units in accordance with the Second Batch of National Key Monitoring Rational Drug Use List （hereinafter referred to as “the List”） issued by the National Health Commission. According to the method of the WHO Guidelines Development Manual， the writing team used the Delphi method to unify expert opinions by reading and summarizing the domestic and foreign literature evidence of related drugs， and applied the evaluation， formulation and evaluation method of recommendation grading （GRADE） to evaluate the quality of evidence formed， focusing on more than 30 drugs in the List about the evaluation of off-label indications of drugs， key points of rational drug use and key points of pharmaceutical monitoring. It aims to promote the scientific standardization and effective management of clinical medication， further improve the quality of medical services， reduce the risk of adverse drug reactions and drug abuse， promote rational drug use， and improve public health.
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At present， there is a lack of unified and standardized management for the rational use of national key monitoring drugs. According to the relevant requirements of the state， based on the relevant literature published at home and abroad in recent years and combined with the management practice of many medical institutions across the country on the national key monitoring drugs， in order to make the national key monitoring drugs more reasonable use and standardized management in medical institutions at all levels， the Clinical Pharmacy Branch of the Chinese Medical Association， the Pharmaceutical Epidemiology Special Committee of the Chinese Pharmaceutical Association and the Pharmaceutical Epidemiology Special Committee of the Sichuan Pharmaceutical Association organized experts to fully discuss， and to form this management standard. This standard mainly provides relevant opinions and suggestions on the basic principles of rational use of key monitoring drugs and the regulatory measures for key monitoring drugs， especially on how to strengthen the pharmaceutical management and use management of key monitoring drugs， further promoting the standardized use of key monitoring drugs.
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OBJECTIVE： To study the relationships of polymorphism of MTRR gene rs1801394 locus and SLCO1B1 gene rs11045879 locus with drug concentration of methotrexate （MTX） and high-dose MTX （HD-MTX）-induced ADR in acute lymphoblastic leukemia （ALL） children. METHODS： From Oct. 2015 to Sept. 2018， 70 ALL hospitalized children of Han nationality in Sichuan area who received HD-MTX treatment and were in consolidation chemotherapy were selected retrospectively from Sichuan People’s Hospital. The blood concentration of MTX at 48 and 72 hours after administration was measured by EMIT. The genetic typing of MTRR gene rs1801394 locus and SLCO1B1 gene rs11045879 locus were detected with real-time PCR. The relationships of the polymorphism of MTRR gene and SLCO1B1 gene with MTX blood concentration [dose-corrected concentration （c48 h/D，48 h）， the proportion of children with different concentration of MTX （≤0.1， ＞0.1 μmol/L）] and ADR （such as myelosuppression， liver function damage， gastrointestinal response， mucosal damage， rash， etc.） were analyzed. Binary Logistic regression analysis for the correlation of ADR with different influencing factors （gene polymor- phism， blood concentration of MTX， immunophenotyping， body mass index， etc.） was carried out by Wald method. RESULTS： Totally 31， 32， 7 children with MTRR gene AA， AG and GG genotype， while 23， 37， 10 children with SLCO1B1 gene TT， TC and CC genotype were detected. The distribution of each genotype in 70 children conformed to Hardy-Weinberg equilibrium （P＞0.05）. There was no significant difference in c48 h/D（48 h） of children and the proportion of children with different concentration of MTX （72 h） among difterent genotypes of MTRR and SLCO1B1 gene （P＞0.05）. There was statistical significance in the incidence of liver function injury in children with different genotypes of MTRR gene （P＜0.05）， and the AA genotype was significantly higher than the AG+GG genotype （P＜0.05）. There was no correlation of MTRR gene polymorphism with the incidence of other ADR， neither SLCO1B1 gene polymorphism with the incidence of ADR （P＞0.05）. The results of Binary Logistic regression analysis showed that liver function damage in ALL children was related to the gene polymorphism of MTRR； gastrointestinal reaction was related to whether the plasma concentration was more than 0.1 μmol/L at 72 h； mucosal damage was related to the immune type and BMI of children； the occurrence of skin allergy was correlated with body weight of children（P＜0.05）. CONCLUSIONS： Gene polymorphism of MTRR rs1801394 locus may associated with the occurrence of HD-HTX-induced liver function injury in ALL children， but its polymorphism and gene polymorphism of SLCO1B1 rs11045879 locus are not related to MTX blood concentration in ALL children.
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OBJECTIVE： To evaluate therapeutic efficacy of reteplase versus alteplase in the treatment of acute myocardial infarction in China， and to provide evidence-based reference for clinical treatment. METHODS： Retrieved from Cochrane library， PubMed， Embase， Medline， CJFD， CSJD， Wanfang database by computor， etc.， also by manual search， RCTs about therapeutic efficacy （recanalization rate of thrombolysis） of reteplase （trial group） versus alteplase （control group） in the treatment of acute myocardial infarction in China were collected from Jan. 1995 to Sept. 2018. After data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0， Meta-analysis was performed for recanalization rate of thrombolysis by using Rev Man 5.3 software. RESULTS： A total of 23 RCTs were included， involving 1 742 patients. Results of Meta-analysis showed that recanalization rate of thrombolysis in trial group was significantly higher than control group， with statistical significance [OR＝0.61，95％CI（0.50，0.73），P＜0.001]. Sub-group Meta-analysis was performed according to the successful time of thrombolysis. Results of Meta-analysis showed that recanalization rate of thrombolysis in trial group 1 h [OR＝0.38，95％CI（0.25，0.58），P＜0.001]， 1.5 h [OR＝0.44，95％CI（0.25，0.79），P＝0.006] and 2 h [OR＝0.62，95％CI（0.42，0.92），P＝0.02] after thrombolysis were significantly higher than control group， with statistical significance. CONCLUSIONS： The recanalization rate of thrombolysis by reteplase in Chinese patients with acute myocardial infarction in better than by alteplase.
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OBJECTIVE:To provide reference for formulating related provisions,guidelines and regulations for off-label drug use,standardizing medical behavior in medical health institutions. METHODS:According to the connotation of off-label drug use,Questionnaire for off-label drug use was developed for medical institutions,in which drug name,treatment disease,the type and use evidence ofoff-label drug usewere included. The questionnaires were delivered to pharmacists who participatedClinical phar-macist practice skills training in Sichuan province to collect the related information of off-label drug use for statistical analysis, and suggestions were put forward. RESULTS:Totally 150 questionnaires were sent out,124 were effectively received with effec-tively recovery of 82.7%;the surveyed pharmacists came from 22 medical institutions,including 18 tertiary hospitals and 4 second-ary hospitals;there were 128 information about off-label drug use,including 14 (10.9%) with incomplete reporting information. The another 114 information were major in“super indication”(61) and“super administration”(43),accounting for 53.5% and 37.7%,respectively,and there are 8 other drug overdose(7.0%),2 super object(1.8%). The relevant off-label drug use mainly included anti-infection drugs (34 information,29.8%),anti-tumor drugs (16 information,14.0%),TCM injections (8 informa-tion,7.0%),and etc.;the relative concentration of varieties were metronidazole,dexamethasone,gentamicin,methotrexate, azithromycin,irinotecan,vancomycin,nystatin,etc.. Some medical institutions were absence of effective regulatory measures. CONCLUSIONS:Off-label drug use is quite common in medical institutions of Sichuan province,some of them exist obvious med-ication risk. It is suggested that the state should be as soon as possible to develop related provisions,guidelines and regulations for off-label drug use,endowing legal force for off-label drug use;medical staff should avoid no evidence-based drug use,unreason-able or even unnecessary off-label drug use;pharmaceutical production enterprises should strengthen communication with medical institutions and pay attention to collect information related to the clinical medication,timely update the drug instructions to ensure the legitimate rights for patients and the interests for medical staff.
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OBJECTIVE:To observe the clinical efficacy and safety of citalopram in the treatment of functional gastrointesti-nal disorders complicated with anxiety or depression. METHODS:62 patients with functional gastrointestinal disorders complicat-ed with anxiety or depression were randomly divided into treatment group(34 cases)and control group(28 cases). Control group was given routine treatment,treatment group was additionally given Citalopram tablet with initial dose of 10 mg,qd,increasing to 40 mg qd,according to the situation of patients,on the basis of control group. Treatment course of 2 groups lasted for 3 months. The gastrointestinal symptom integral,HAMD and HAMA were compared between 2 groups before and after treatment,and clini-cal efficacy and the occurrence of ADR were observed. RESULTS:There was no statistical significance in gastrointestinal symptom integral,HAMD and HAMA between 2 groups before treatment (P>0.05). After Treatment,above scores of 2 groups decreased significantly,and the treatment group was lower than the control group,with statistical significance(P<0.05). Total effective rate of treatment group was significantly higher than that of control group (94.12% vs. 67.86%),with statistical significance (P<0.05). Olny 4 patients of treatment group suffered from mild ADR. CONCLUSIONS:Citalopram shows significant therapeutic effi-cacy in the treatment of functional gastrointestinal disorders complicated with anxiety or depression,and can improve digestive tract symptom and anxiety or depression,and help to improve patients’gastrointeseinal symptoms with good safety.
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OBJECTIVE:To understand the application of proprietary Chinese medicine by clinicians in integrated medical insti-tutions,and provide reference for its rational use. METHODS:The questionnaire was designed,including related issues of proprie-tary Chinese medicine clinical application(such as medication basis of proprietary Chinese medicine,combined medication,clini-cal efficacy and its influencing factors,medication for special groups and so on)and suggestions;the questionnaires were delivered to the clinicians who worked in some second and third grade of integrated medical institutions located in southwestern regions and Chengdu,and the questionnaires was in the form of an anonymous;relevant data of available questionnaire were collected statisti-cally;the application situation of proprietary Chinese medicines and the existence question were analyzed,and suggestions were put forward. RESULTS:Totally 300 questionnaires were sent out,264 were effectively received,with effective rate of 88.0%. The clinicians involved in investigation were mainly in undergraduate,mostly the resident physicians and attending physician;only 6.8%of the physicians received the training of basic theory of traditional Chinese medicine after work;36.4%physicians often pre-scribe proprietary Chinese medicines,and the medication basis was mainly in package insert (64.0%) and clinical experience (55.3%);51.1% thought unclear indications affected the application of proprietary Chinese medicines,64.0% thought package in-sert can not meet clinical needs. In terms of answers in brief questions,the surveyed clinicians generally considered the package in-sert was too simple,which needed further perfected. CONCLUSIONS:The problems in clinical application of proprietary Chinese medicines should not be ignored. The relevant departments should strengthen the supervision of clinical application of proprietary Chinese medicines,and strengthen the re-evaluation of proprietary Chinese medicines market,as to provide data support for the continuous improvement of package insert. Medical institutions should carry out training timely for the physicians who prescribe pro-prietary Chinese medicines,the pharmacists should strengthen checking of proprietary Chinese medicines prescription and special prescription comment,and ensure prescription checking and comment play a active role in promoting rational drug use based on“proprietary Chinese medicines clinical application guiding principle”“prescription management method”.
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OBJECTIVE:To investigate the role of compatibility on clinical efficacy action of the prescription containing Curcu-ma zedoaria,and to improve the pertinence of drug use by medical staff and clinical efficacy of C. zedoaria. METHODS:By re-viewing relevant literatures,the prescriptions containing C. zedoaria were selected to summarize the effects of compatibility on clini-cal efficacy of C. zedoaria. RESULTS:345 prescriptions containing C. zedoaria were collected,mainly including the compatibility of C. zedoaria with traditional Chinese medicine which promote the circulation of qi,activate blood and remove blood stasis,toni-fy deficiency,warm interior and clear heat. The prescriptions containing C. zedoaria with sparganii often included Rhizoma Sparga-nii and C. zedoaria,involving 219 prescriptions(13.94%). CONCLUSIONS:C. zedoaria have the effects of activating blood stag-nation,promoting the circulation of qi,removing food retention and relieving pain;different compatibility greatly influence the clinical efficacy of C. zedoaria;common couplet medicines are R. Sparganii and C. zedoaria,and it can play the role of activating blood stagnation,promoting the circulation of qi,removing food retention and relieving pain;Common Vladimiria Root combined with Rheum palmatum can promote the circulation of qi and relieve pain. Medical staff should prescribe the prescriptions and use drugs for the compatibility of C. zedoaria based on clinical demands.
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Objective To systematically evaluate the efficacy and safety of telmisartan and amlodipine in treatment of hypertension complicated with diabetes.Methods Retrieved from PubMed, EMBASE, Cochrane library, CNKI, VIP and Wanfang database by computer, randomized controlled trials( RCTs) about telmisartan versus amlodipine in treatment of hypertension and diabetes were collected, then relevant date were extracted, Meta-analysis was drawn by RevMan 5.3 statistical software.Results A total of 11 RCTs were included involving 914 patients.The results of Meta-analysis revealed that telmisartan was better than amlodipine in fasting blood glucose reduction[MD =-0.54,95%CI( -0.87, -0.21),P =0.001], glycosylated hemoglobinreduction[MD=-0.60,95%CI( -1.12,-0.07),P =0.03] and HOMA insulin resistance index reduction[MD =-1.27, 95%CI( -1.81,-0.73),P<0.001],there were statistical significance.There were no significant difference in systolic blood pressure[MD =2.39, 95%CI( -0.21,4.98),P=0.07],diastolic blood pressure[MD =0.17,95%CI( -0.95,1.29),P =0.77] and adverse drug reaction[RR=0.70, 95%CI(0.41,1.19),P=0.19].Conclusion For patients with hypertension and diabetes, telmisartan in decreasing fasting blood glucose, glycosylated hemoglobinand HOMA insulin resistance index is more effective than that of amlodipine, blood pressure in patients with equivalent,antihypertensive and safety are similar.
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Objective:To explore the pharmaceutical care for special tumor patients performed by clinical pharmacists. Methods:Using one patient with breast cancer and hepatitis B virus infection as the example, clinical pharmacists participated in the clinical medicine therapy. Cooperating with the clinical physician, clinical pharmacists made an overall therapy regimen for the patient. On the basis of chemotherapy regimen and combining with the actual conditions of the patient, clinical pharmacists comprehensively considered the relevant therapeutic factors, such as antiviral, anti-nausea, hepatoprotective and increasing white cells therapy, and performed the corresponding regimen. In the treatment process, clinical pharmacists provided the real-time pharmaceutical care and tracking evalua-tion for the patient as well. Results: With close collaboration with clinical pharmacists and physicians, the patient obtalned perfect medicine therapy and pharmaceutical care, which made the biochemical indices ( liver enzymes, blood, hepatitis B virus load etc) tend to normal in the whole course of chemotherapy and help the patient complete the chemotherapy. Conclusion:Clinical pharmacists in-volved in clinical medicine treatment especially for special and complex diseases can make clinical medication more rational, which helps achieve the goal of treatment and reduce adverse drug reactions at the same time, and is benefit to the improvement of patient compliance and clinical medication level.
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OBJECTIVE: To investigate the characteristics and regularity of ADR cases caused by leflunomide, and to provide reference for rational use of it. METHODS: Literatures about leflunomide-inducing ADR were retrieved from CNKI between 1994 and Apr. 2010. Those literatures were statistically analyzed in respect of patient’s age and gender, route of administration, dosage of drugs, onset time of ADR, organs and systems involved in ADR and its clinical manifestations, treatment and outcomes, etc. RESULTS: 37 pieces of literatures were obtained with standard cases of 45. The incidence of ADR cases in female(75.56%) was higher than in males (24.44%). 28 ADR cases were in 50～60 group. 39 patients were treated with leflunomide 10～30 mg once a day. After treatment, the most common gastrointestinal adverse events occurred in 1～15 d. Leflunomide-inducing ADR was digestive system reaction (75.56%) the most. Patients who took medicine less than 10 days with mild ADR need not to stop taking medicine when clinical symptoms reduced or disappeared after symptomatic treatment. Patients who took medicine more than 10 days with severe ADR need to stop taking medicine and receive symptomatic treatment. CONCLUSION: Clinical physicians should pay attention to rational use of leflunomide and ADR during treatment course to reduce the harm due to adverse events.
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OBJECTIVE: To construct informational pharmaceutical care system(IPCS) for clinical pharmacists and to improve the level of pharmaceutical care.METHODS: By means of the latest ideas on pharmaceutical care and the support of local area network technology of Hospital Information System,the construction and running of IPCS for clinical pharmacists were illustrated using clinical cases.RESULTS: Based on the establishment of pharmaceutical record database,we could realize the integration of IPCS which included the automatic monitoring of important drugs and bacteria,clinical pharmacist consultation,information collection,information publication,information inquiry,medication counseling,establishment of specialized pharmaceutical staff and online further education,etc.CONCLUSION: The pharmaceutical care based on information platform is a good practice model for clinical pharmacy.It is the only way for clinical pharmacists to carry out further development of pharmaceutical care.
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OBJECTIVE:To study the effects of clozapine on blood glucose and insulin levels in schizophrenic patients. METHODS:This is a self-controlled study in which the levels of blood glucose and insulin in clozapine group(n=63) were compared before and after treatment,and which were compared with the levels in the control group(n=64).Insular cellular antibody(ICA) and insulin autoantibody(IAA) were detected in patients with high level of blood glucose.RESULTS:After treatment for 8 weeks,the blood glucose level was increased in clozapine group as compared with the same group before treatment and the control group,showing significant differences(P
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OBJECTIVE:To provide references for the management and use of the donated drugs for earthquake resistance and disaster relief.METHODS:The problems appeared in the management and use of the donated drugs after the earthquake occurred on May 12,2008 in Sichuan province of China were summarized analytically and the corresponding suggestions were put forward.RESULTS & CONCLUSION:Some problems such as the turnover of the drugs,the expiration date,drug dispensing and allocation etc appeared in the management and use of the donated drugs,which should be standardized by setting related laws and regulations to make more greater use of the limited drug resource in the disaster relieving.
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OBJECTIVE: To explore an effective approach for clinical pharmacists to provide pharmaceutical care to outpatients.METHODS: Based on our personal experience and the mode of pharmaceutical consultation service in our hospital as well as the case study,the setting up and operational model of drug consultation service for outpatients were introduced.RESULTS & CONCLUSIONS: If requirements on personnel and hardware & software satisfied,setting drug consultation service for outpatients that operated in 5 steps including probing into patient's basic condition and analyzing patient's medication condition etc can greatly enhance patients' medication compliance.
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OBJECTIVE: To establish GC-MS method for the determination of the Menthol in inclusion complex of compound essential oil-? -cyclodextrin. METHODS: Menthol was determined with ion fragment peak ( M/Z=71) . The chromatographic column was DM-5 fused silica capillary column ( 0. 25mm? 30m) ; the internal standard was naphthol and the temperature programming was 80～ 180℃ . RESULTS: The calibration curves of Menthol were linear in the ranges of 1. 344～ 10. 752? g? mL-1( r=0. 999 8) and the average recovery was 97. 52% , RSD=1. 56% . CONCLUSION: The method is rapid, accurate and reproducible, and suitable for the quality control of the same kind of the preparation.
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To establish a method for the deter mination of dissolution of amiodarone hydrochloride tablets. Methods: Samples from five different factories were tested by the paddle meth od with the dissolving medium of 1% SLS. Results: The resu lts showed that there were very significant differences(P＜0.01) in dissolut ion parameters among the tested samples. Conclusion: It is necessary for testing the dissolution of the amiodarone product to control its quality and ensure clinical efficacy and safety.
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OBJECTIVE:To evaluate the distribution and drugs resistance of pathogenic bacteria causing nosocomial infection over 2 years in our hospital.METHODS:A total of 4 653 strains of pathogens were analyzed statistically by retrospective study.RESULTS:Among 4 653 strains of pathogens,709 were fungi(15.2%),1 078 were Gram-positive cocci(23.2%)and 2 866 were Gram-negative bacilli(61.6%).Over the 2 years,the detection rates of extended spectrum ?-lactamase-producing Escherichia coli and Klebsiella spp.were 36.5% and 27.9%,respectively.The average resistance rate of Gram-positive cocci to penicillin,oxacillin,cefazolin,erythromycin,Co-trimoxazole and ciprofloxacin over the 2 years were 84.5%.The average resistance rate of Gram-negative bacilli to ampicillin was 96.0% and to cefotaxime,cefepime,gentamycin,Co-trimoxazole,ciprofloxacin and aztreonam were 52.7% in 2 years.CONCLUSION:Over the 2 years,Gram-negative bacilliin strains causing hospital nosocomial infections increased,Gram-positive cocci strains remain stable,but fungous infection showed a decline tendency.In view of the increasing drug resistance,rational use of antimicrobial agents should be stressed in the clinic.
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OBJECTIVE:To establish a RP-HPLC method for content determination of costunolide in Liqifuwei oral liquid.METHODS:The assay was performed on a Luna C 18 column by UV detector at the wavelength of225nm with methanol-water(72∶28)as the mobile phase at the flow rate of1.0ml/min.RESULTS:The amount of costunolide was linear with its area over the range from0.2?g～2.0?g(r=0.9996),the average recovery was98.4%(RSD=0.85%).CONCLUSION:The present method is convenient,sensitive and accurate with good reproducibility and can be used for the quality control of Liqifuwei oral liquid.